Investigational Antibiotic Receives Orphan Drug Status for CF Pulmonary Exacerbations
The FDA has granted Orphan Drug designation to ARV-1801 (sodium fusidate; Arrevus) for the treatment of pulmonary exacerbations in patients with cystic fibrosis.
All articles by Steve Duffy
Point-of-Care MRI System Granted FDA Clearance
The FDA has granted 510(k) clearance to the Hyperfine system, a bedside magnetic resonance imaging system.
Three-Drug Combination Receives FDA Priority Review for HAP, VAP
The FDA has accepted for review a supplemental New Drug Application for Recarbrio™, to treat adult patients with hospital-acquired and ventilator-associated bacterial pneumonia.
FDA: Possible Cybersecurity Issues With Certain Patient Monitoring Devices
The FDA has issued a safety communication informing healthcare providers, facilities, and patients about cybersecurity vulnerabilities associated with certain GE Healthcare Clinical Information Central Stations and Telemetry Servers.
Influenza Vaccine for Older Adults Granted Fast Track Status
The Food and Drug Administration has granted Fast Track designation to NanoFlu (Novavax) for seasonal influenza vaccination in adults ≥65 years.
Haymarket Medical Education Receives Interprofessional Joint Accreditation for the Healthcare Team
Caroline O. Pardo, Ph.D., General Manager for Haymarket Medical Education, is pleased to announce that HME, based in Paramus, NJ, has been accredited as a provider of interprofessional continuing education by the Accreditation Council for Continuing Medical Education, the Accreditation Council for Pharmacy Education, and the American Nursing Credentialing Center.
FDA: Do Not Use Products Distributed by Basic Reset, Biogenyx
The FDA is reminding consumers not to use drugs, dietary supplements or medical device products distributed by Basic Reset or Biogenyx.
Baloxavir Marboxil Approved in Patients at High Risk for Flu-Related Complications
The FDA has approved a supplemental NDA for Xofluza for the treatment of acute, uncomplicated influenza in patients aged 12 years and older.
Benralizumab Approved for Self-Administration With New Prefilled Autoinjector
The FDA has expanded the approval of Fasenra (benralizumab; AstraZeneca) to include self-administration with the Fasenra Pen, a prefilled, single-use autoinjector.
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